Manager of Clinical Database Programming

Worldwide Clinical Trials - Durham, NC

Full-time - Manager

Durham, NC

1,001-5,000 employees

Chemical Manufacturing

About the position

The Manager of Clinical Database Programming at Worldwide Clinical Trials is responsible for overseeing the Data Management Department, ensuring the effective allocation of staff, training, and adherence to standard operating procedures (SOPs). This role involves managing data management projects to meet time, budget, and quality standards while providing leadership to the data management teams. The position requires a focus on data accuracy and integrity, crucial for regulatory submissions, and involves collaboration with various stakeholders, including sponsors and regulatory authorities.

Responsibilities

• Manage assigned departmental personnel and ensure sufficient expertise through staff allocation.
• Identify training requirements and provide necessary training for staff.
• Conduct staff appraisals and contribute to the strategic management of the department.
• Write and review departmental SOPs and ensure compliance with WCT SOPs in data management operations.
• Assist with budget and resource needs at the department and project level, including input on project proposals.
• Manage and ensure timely, budget-compliant, and quality delivery of data management projects.
• Perform quality control checks and database quality assessments on clinical databases of assigned projects.
• Represent the company at meetings with sponsors and committees, providing support to Business Development staff.
• Participate in sponsor audits, regulatory authority inspections, and other third-party meetings.

Requirements

• Several years of experience in Data Management, preferably in a CRO or pharmaceutical industry.
• 5 years of management experience with proven team management skills.
• Demonstrated ability to lead staff in a global environment.
• Broad knowledge of data management processes.
• University/college degree preferred or equivalent combination of education and experience.

Nice-to-haves

• Experience with various computer systems and adaptability to new technologies.
• Proven project delivery experience.

Benefits

• Diverse and inclusive work environment.
• Opportunities for personal and professional growth.
• Supportive leadership and cohesive teams.